Merck & Co. Earnings Call Transcripts
Fiscal Year 2026
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Transformation is ahead of schedule, with strong progress in oncology, HIV, and ophthalmology. The pipeline is robust, featuring differentiated ADCs, mRNA therapies, and novel cardiometabolic and immunology assets, with over 20 late-stage assets expected to drive significant growth.
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Recent phase III data in NSCLC and melanoma highlight durable efficacy for new combinations, while dose optimization and improved AE management support broader use of ADCs. Strategic acquisitions and partnerships are expanding the pipeline in CML and multiple solid tumors, with a strong focus on data-driven development.
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Significant progress was highlighted in oncology, with KEYTRUDA's expansion into earlier-stage indications, a diversified late-stage pipeline, and strong clinical data for sac-TMT and other novel assets. Commercial momentum is robust, with new launches and a projected $25B+ opportunity by the mid-2030s.
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The meeting highlighted strong financial growth, a robust late-stage pipeline, and major investments in R&D and manufacturing. All board nominees and management proposals were approved, while shareholder proposals on DEI, healthcare coverage, and political contributions were not.
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Q1 revenue grew 5% year-over-year to $16.3B, led by oncology and animal health, but a $9B one-time charge for Sedera resulted in a reported loss. Guidance for 2026 was raised, with continued investment in launches and pipeline, and the Terns acquisition expected to further diversify growth.
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The acquisition of Terns Pharmaceuticals for $6.7 billion adds TERN-701, a next-generation CML therapy with best-in-class potential, to the hematology pipeline. The deal is expected to close in Q2 2026, driving long-term growth and leveraging existing commercial strengths.
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The company is launching over 20 new human health products and expects animal health revenues to double by the mid-2030s. Key late-stage pipeline assets target major unmet needs, with strong growth anticipated post-KEYTRUDA exclusivity loss. Diversification in oncology, cardiometabolic, and vaccine portfolios is central to the next decade’s strategy.
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A diverse late-stage pipeline and disciplined business development have positioned the company for over $70 billion in commercial opportunities by the mid-2030s. Key product launches, accelerated clinical programs, and strategic acquisitions support confidence in managing the Keytruda LOE and sustaining long-term growth.
Fiscal Year 2025
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Q4 2025 revenue grew 5% to $16.4B, led by oncology and new launches, while animal health also performed strongly. 2026 guidance projects 1–3% revenue growth, with continued investment in pipeline and launches, despite headwinds from generic competition and pricing pressures.
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Key highlights include a $5B+ opportunity for a novel influenza antiviral, strong uptake and expansion for WINREVAIR in PAH, and robust progress in oral PCSK9 and immunology pipelines. Oncology launches and external funding deals are supporting a broad, high-impact late-stage portfolio.
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Key pipeline programs advance with phase 3 starts in pulmonary hypertension, strong growth for WINREVAIR, and a promising oral PCSK9. Ophthalmology and immunology assets target large unmet needs, while lifecycle management for KEYTRUDA and new HIV anchors are prioritized.
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Multiple milestones were highlighted, including the Cidara acquisition for a long-acting antiviral, strong progress in PAH and rare disease programs, and rapid advancement of new assets in ophthalmology and HIV. The pipeline features transformative therapies with broad regulatory and market interest.
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The acquisition brings a first-in-class, long-acting antiviral for influenza, targeting a large unmet need in high-risk populations. The $9.2 billion deal is expected to drive significant growth, with CD388 offering over $5 billion in commercial potential and leveraging existing infrastructure.
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Panelists highlighted rising vaccine hesitancy, the enduring trust in healthcare professionals, and the importance of local voices and robust communication. Innovations in R&D, AI, and global partnerships are shaping access and future vaccine development, with cancer vaccines and rapid-response platforms seen as key growth areas.
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MK-0616 (Enlisted) demonstrated robust, durable LDL-C lowering of up to 59.7% with a placebo-like safety profile and high adherence, positioning it as a leading oral add-on therapy for cardiovascular risk reduction. Regulatory filings are planned for early 2026, with significant commercial potential projected for the cardiometabolic and respiratory portfolio.
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Q3 saw 4% revenue growth to $17.3B, led by oncology, animal health, and new launches. Guidance for 2025 is $64.5–$65B in revenue and $8.93–$8.98 EPS, with strong pipeline momentum and new product approvals offsetting vaccine and LOE headwinds.
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A major transformation is underway, shifting from reliance on a single product to a diversified launch strategy with over 20 new molecular entities and a $50B+ commercial opportunity by the mid-2030s. Key growth drivers include robust oncology, HIV, ophthalmology, and animal health pipelines, proactive pricing strategies, and global expansion, with strong clinical progress in WINREVAIR and ADCs.
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Management highlighted a robust pipeline with 20 launches underway, aiming for over $50B in revenue by the mid-2030s. KEYTRUDA growth is expected to continue with new indications and a subcutaneous formulation, while diversification in oncology and non-oncology assets, business development, and disciplined financial strategy underpin long-term growth.
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Q2 revenue reached $15.8B, down 2% due to GARDASIL China, but underlying growth was 7% with strong oncology and animal health performance. New launches like WINREVAIR and CAPVAXIVE are driving momentum, and a $3B optimization initiative will fund pipeline expansion. Guidance for 2025 remains solid.
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A robust late-stage HIV pipeline is advancing, featuring daily, weekly, and monthly oral regimens for both treatment and PrEP. Key programs show strong efficacy, safety, and patient preference for long-acting options, with a commercial opportunity exceeding $5 billion by the mid-2030s.
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The acquisition brings a first-in-class COPD therapy with strong clinical and commercial momentum, expanding the cardiopulmonary portfolio and supporting long-term growth. The $10B deal is expected to be accretive over time, with robust patent protection and significant market opportunity.
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Leadership outlined a transformative period with nearly 20 new launches across diverse therapeutic areas and a projected $50B+ revenue opportunity by the 2030s. Ongoing policy discussions, manufacturing pivots, and robust pipelines in cardiometabolic, oncology, and animal health support a strong growth outlook.
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The event highlighted a diversified oncology strategy, with KEYTRUDA’s expanding indications and a robust late-stage pipeline featuring subcutaneous pembro, novel ADCs, and targeted agents. Key clinical data showed advances in lung, breast, and hematologic cancers, while commercial plans target broad adoption and sustained leadership.
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The event highlighted robust pipeline expansion, strategic manufacturing shifts, and a diversified approach to business development. Key launches like WINREVAIR and the subcutaneous Keytruda formulation are expected to drive growth, while margin management and a $50B+ pipeline revenue target underpin long-term confidence.
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The meeting highlighted strong financial growth, a robust and diversified pipeline, and major investments in R&D and manufacturing. All board nominees and management proposals were approved, while none of the four shareholder proposals passed. Key risks included regulatory changes and market dynamics.
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Policy uncertainty around MFN and IRA is driving significant internal focus, with ongoing questions about implementation and commercial impact. Keytruda remains a growth driver, with new launches and pipeline expansion aimed at offsetting future LOE. GARDASIL growth continues outside China, and innovation in oncology and vaccines remains a priority.
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Q1 revenue reached $15.5B, with strong growth in oncology, animal health, and new launches, offset by a Gardasil sales decline in China. Full-year guidance is maintained, with robust pipeline progress and strategic U.S. manufacturing investments supporting long-term growth.
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Strong growth is projected through oncology, animal health, and new launches, with a robust late-stage pipeline and strategic business development. Key products like Winrevair, Welireg, and Keytruda Sub-Q are advancing, while global expansion and innovation remain central.
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Consistent revenue growth and a diversified pipeline underpin a positive long-term outlook, with major launches and data readouts expected in 2024–2025. Oncology, vaccines, and HIV are key growth areas, while GARDASIL China and FX remain headwinds.
Fiscal Year 2024
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Strong Q4 and 2024 growth was driven by oncology, animal health, and new launches, offsetting Gardasil's China headwinds. Guidance for 2025 anticipates continued robust growth, with a diversified pipeline and new products supporting long-term confidence.
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The conference highlighted optimism for policy improvements, robust vaccine and oncology portfolios, and strong global growth prospects. New launches like Capvaxive, clesrovimab, and Winrevair are set to drive future performance, while a diverse and expanding pipeline underpins long-term confidence.
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Revenue guidance was raised with strong growth outside China, and major commercial opportunities identified in oncology, cardiometabolic, and immunology. The pipeline features promising oncology assets, a robust oral PCSK9 program, differentiated obesity strategies, and next-gen vaccines and HIV PrEP candidates.
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Management outlined a robust oncology pipeline, rapid drug development capabilities, and strategic global expansion for vaccines. Subq Keytruda and next-gen ADCs are positioned for broad impact, while Gardasil's growth will rely on new markets and innovations.
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Q3 delivered strong growth across human and animal health, with robust launches and pipeline momentum. GARDASIL and KEYTRUDA continue to expand globally, while WINREVAIR and pipeline assets advance in late-stage trials. Policy changes and new indications are expected to drive future growth.
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Q3 revenue grew 4% (7% ex-FX) to $16.7B, led by Keytruda (+21%) and new launches, while Gardasil declined 10% due to China. 2024 guidance narrowed to $63.6–$64.1B, with solid 2025 growth expected from oncology, new products, and animal health despite Gardasil headwinds.
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Strong operational momentum and pipeline expansion are driving double-digit international growth, with Keytruda and Gardasil as key contributors. Diversification efforts include new launches in cardiovascular, immunology, and vaccines, supported by robust business development and global partnerships.
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Management highlighted robust pipeline growth, confidence in Gardasil’s global expansion, and a disciplined, science-driven approach to business development. Winrevair’s launch is on track, with European and future China opportunities, while key pipeline assets in IBD, pneumococcal, and HIV are advancing.
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Q2 2024 saw strong revenue and EPS growth, led by oncology and new product launches. Guidance was raised despite Gardasil shipment challenges in China, with robust global demand and pipeline progress supporting long-term confidence.
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Strong progress across oncology, cardiometabolic, immunology, and animal health portfolios, with robust phase II/III pipelines and successful product launches like WINREVAIR. Strategic M&A, early partnerships, and innovation in key assets support growth into the 2030s.